BEUDAMED
    17 results · 28ms · Sources: EU EUDAMED, US FDA

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    Apex 3D Total Ankle Replacement System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Accufit

    FDA UDI
    Ortho Organizers, Inc.·00190707185275·AccuFit™ Molar Band UL7 - 39

    PMT CORPORATION - STEREOTACTIC

    FDA UDI
    PMT CORPORATION·00650551039907·DEPTH STOP FOR ANCHOR BOLT, FOR 2.7MM DRILL

    ETG 255 COMBO STIMUALTOR, TEN 260 STIMUALTOR

    FDA 510(k)
    FDA Class 2 ·Neurology

    ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TROCHANTERIC NAIL KIT, TI GAMMA3 11X180MM X 130

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·June 14, 2012

    ACIST

    FDA Adverse Event
    Injury ·ACIST MEDICAL SYSTEMS, INC.·Product code DXT·February 10, 2012

    SINGLE 8 EXTENSIONS

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 9, 2011

    HEARTSTART XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·August 8, 2014

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·July 8, 2013

    ACIST

    FDA Adverse Event
    Malfunction ·ACIST MEDICAL SYSTEMS, INC.·Product code DXT·April 20, 2007

    ACIST

    FDA Adverse Event
    Injury ·ACIST MEDICAL SYSTEMS, INC.·Product code DXT·February 10, 2012

    ARCOS 14X150MM SPL TPR DIST HA X 150MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·February 26, 2021

    ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025